Preoperative or Postoperative Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer

NCT ID: NCT00193310

Last Updated: 2015-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2009-01-31

Brief Summary

In this phase II study, we plan to evaluate several novel components of therapy. In patients with potentially resectable stages IIB (T3N0) and IIIA we will compare weekly paclitaxel and carboplatin with concomitant radiation therapy versus weekly paclitaxel and every 4 week carboplatin in the preoperative (neoadjuvant) setting. For patients with potentially resectable stage IB, IIA and IIB (T2N1) tumors, weekly paclitaxel and every 4 week carboplatin will be given pre-operatively (neoadjuvant). The feasibility of resection will be evaluated in the neoadjuvant group of patients. The continued study of concurrent radiation therapy with weekly paclitaxel and carboplatin will be evaluated in those patients with stage IIB (T3N0) and IIIA disease who initially had resection (adjuvant setting). Lastly, weekly paclitaxel and carboplatin every 4 weeks will be evaluated as an adjuvant program in patients who had completely resected stage IB, IIA and IIB (T2N1).

Detailed Description

Upon determination of eligibility, neo-adjuvant patients will be randomly assigned to one of two treatment arms:

• ARM A Paclitaxel + Carboplatin + Radiation Therapy + Surgery
• ARM B Paclitaxel + Carboplatin + Surgery

After surgery neo-adjuvant patients with a complete resection will either receive Paclitaxel + Carboplatin or no therapy, depending on their stage of disease at time of enrollment. Patients with incomplete resection Paclitaxel + Carboplatin + Radiation Therapy. Adjuvant patients who enter the study after complete resection will receive Paclitaxel + Carboplatin with or without Radiation Therapy based on initial stage of disease.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Paclitaxel

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

To be included in this study, you must meet the following criteria:

• Non-small cell lung cancer
• Neoadjuvant candidates must have potentially resectable disease
• Adjuvant candidates must have had complete resection
• Clinical stage IB, II, or IIIA non-small cell lung cancer
• ECOG performance status 0 or 1
• Adequate bone marrow, liver and kidney function
• No previous chemotherapy or radiation therapy for non-small cell lung cancer.
• Give written informed consent.

Exclusion Criteria

You cannot participate in this study if any of the following apply to you:

• Stage IIIA with N2 nodes > 6 cm
• Stage IIIB or IV disease
• Age <18 years
• ECOG performance status 2 or higher
• Considered inoperable based on general medical condition
• History of prior malignancy within five years
• Women who are pregnant or lactating

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Principal Investigators

Anthony Greco, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Other Identifiers

SCRI LUN 53

Identifier Type: -

Identifier Source: org_study_id